"Rocket Heart" Over 15 Years: Applying Aerospace Rigor to Engineer Every Artificial Heart

Heart failure is a disease caused by impaired cardiac pumping function.

In the early stages, patients may experience symptoms such as shortness of breath, chest tightness, and fatigue, which impair their normal daily life. In recent years, there have been numerous breakthrough advancements in heart failure medications; however, these treatments can only slow disease progression and cannot achieve a complete cure.When heart failure progresses to the end stage, it poses an imminent threat to the patient’s life, and only heart transplantation offers a chance of survival.

The shortage of donor hearts is a common challenge faced by heart failure patients worldwide. In 1978, American scientist Jarvik developed the “Jarvik model” of the artificial heart and created the first permanent total artificial heart, marking a significant milestone in artificial heart technology.

Since then, researchers have continuously conducted studies on artificial assist hearts. Although China started later, it has made rapid progress in the past decade.In 2022, the “Rocket Heart”—HeartCon Implantable Left Ventricular Assist System (hereinafter referred to as “Rocket Heart”), an artificial heart with fully independent intellectual property rights independently developed by Rocketheart Technology Co., Ltd. (hereinafter referred to as Rocketheart), obtained the National Class III Medical Device Product Registration Certificate and was successfully approved for market launch.

Han Zhifu, General Manager of Rocketheart Technology Co., Ltd., told VCBeat: “Our mission is not only to develop a safe and reliable ‘rocket heart,’ but also to make it affordable for the general public. This is the mission and responsibility of aerospace professionals.”

As of 2023, there were approximately 13.7 million patients with heart failure in China. With the progression of population aging, this figure continues to rise annually.However, only more than 70 medical institutions in China are qualified to perform heart transplants. Due to a severe shortage of donor hearts, only 941 heart transplant procedures were performed in 2023.Han Zhifu stated, “This is inextricably linked to China’s national conditions.”

Death criteria are a significant factor affecting the quantity and quality of donors.In China, death is determined by the cessation of respiration, cardiac activity, and pulse, rather than by “brain death.” However, if the warm ischemia time of the heart exceeds 10 minutes, it becomes unsuitable for use as a donor organ. Additionally, the cold ischemia time for the heart is limited to only 6–8 hours.China’s Vast Territory Poses Significant Challenges for Donor Organ Transportation. Meanwhile, influenced by traditional concepts such as “the body, hair, and skin are gifts from one’s parents,”A significant portion of the population finds it difficult to accept organ donation.

Although attitudes toward organ donation have improved among some segments of the population in recent years with societal progress, cardiac donors still fail to meet the needs of patients with heart failure due to constraints related to death determination criteria and transportation logistics.Mechanical circulatory support has become the most realistic treatment option for patients with end-stage heart failure amid a shortage of cardiac donors.

An artificial assistive heart refers to a device that uses mechanical or biomechanical means to partially or completely replace the natural heart in establishing and maintaining hemodynamic circulation in the human body. However, Han Zhifu corrected this terminology, stating, “The term ‘artificial heart’ is actually a misnomer.”

The English abbreviation for an artificial heart is LVAD, which formally translates to Left Ventricular Assist Device. It was simplified to “artificial heart” upon its introduction to China to facilitate broader dissemination.As can be seen from the official translated name, the left ventricle and assistance are key to this device.

Although the indications for artificial hearts are limited, the vast patient population and the heavy social and economic burden make this market size not to be underestimated. In Han Zhifu’s words, “This is a niche sector with a market value in the tens of billions.”

The development of artificial assist hearts involves a multidisciplinary spectrum encompassing systems engineering, electrical and electromagnetic engineering, motor control and drive, fluid machinery, bioengineering, precision machining, and quality management. This endeavor imposes stringent requirements on the comprehensiveness of disciplinary technical reserves and the richness of engineering translation experience.

To break the monopoly of foreign companies,The Beijing Research Institute of Precise Mechatronic Control Equipment, under the China Academy of Launch Vehicle Technology, established an engineering team and collaborated with a medical team from Tianjin TEDA International Cardiovascular Hospital, represented by President Liu Xiaocheng., practicing the development path of combining medicine and engineering as well as military-civilian integration, to develop domestically produced artificial hearts,In 2016, Rocketheart Technology Co., Ltd. was established in the Tianjin Economic-Technological Development Area.

The ventricular assist device is implanted directly into the human thoracic cavity and closely connected to the heart, the body’s most vital organ. Biocompatibility is a critical consideration for ventricular assist devices, as it directly impacts their safety and efficacy.Poor biocompatibility may lead to complications such as hemolysis and thrombosis, posing risks to patient health—this is also a major technical challenge in the development of artificial hearts.

First, an artificial heart must ensure adequate blood flow during operation while avoiding damage to red blood cells. Han Zhifu offered a vivid analogy: “It’s like tomatoes floating in an irrigation canal. Installing a pump in the canal requires propelling the water forward without crushing the tomatoes.”

To address this issue, Rocketheart Technology Co., Ltd. has conducted in-depth exploration in areas such as material selection, blood flow pathways, and surface structure, thereby establishing its own technological moat in key aspects.

After countless attempts and validations, the team overcame the technical barrier of blood compatibility in 2013.The entire implantable blood pump device weighs only 186 grams, with a diameter of 50 millimeters and a thickness of approximately 30 millimeters., neither the implantation procedure nor subsequent use imposes an excessive burden on patients.

In 2013, the experimental sheep "Tianjiu," implanted with the "Rocket Heart," survived healthily for 120 days at the Animal Experiment Center.Achieved Five Firsts, Including the Longest Survival Record in China. Batch experiments conducted in October 2017 further demonstrated that all six animals survived healthily for more than 90 days, with the longest survival reaching 180 days, and all organs remained in good condition.This also demonstrates that both biocompatibility and hemodynamic parameters have reached the level required for clinical application.

Beyond safety, the degree of mechanical circulatory support provided by an artificial heart requires precise calibration to achieve an optimal balance. Insufficient support yields suboptimal clinical outcomes after implantation; conversely, excessive support can deprive the native heart of its residual contractile function, leading to myocardial atrophy and organ disuse.

To determine the optimal assist flow rate for each patient, medical staff must conduct individualized assessments and adjust the artificial heart based on patient-specific data prior to implantation, thereby ensuring the most appropriate circulatory support.

In 2022, the implantable left ventricular assist system HeartCon (“Rocket Heart”), developed by Rocketheart Technology Co., Ltd., was officially approved for market launch.This is also China’s first implantable left ventricular assist system adopting magnetic-levitation technology with fully independent intellectual property rights, and its key technical indicators have reached international parity.

Meanwhile, the realization of domestic substitution has significantly reduced costs,reducing the price of artificial hearts from over $100,000 to a range affordable for the general public.In the future, as the scale of application expands, prices will further decrease, bringing hope for life to more heart failure patients!

Looking back on the 15-year journey of the “Rocket Heart,” what Han Zhifu finds most memorable, aside from each moment when a key technical hurdle was overcome, is the team’s repeated processes of bonding and coordination.

When the team decided to develop a ventricular assist device (VAD) in 2009, they were filled with uncertainty: “Let alone understanding artificial hearts, none of us could even read biology literature.” Although the team members were experts in engineering, with many having participated in the research, development, and manufacturing of multiple rocket models, they were completely unfamiliar with the medical field. Doctors from TEDA International Cardiovascular Hospital helped bridge this gap.

For industrial products, ensuring functional feasibility is the primary requirement. However, when integrated with clinical practice, product form becomes particularly important.

Furthermore, the human body is not a machine. In traditional devices, faulty components can be repaired or replaced at any time; however, products implanted in the human body must be designed for long-term use to minimize the risk of secondary harm to patients.

The Various Forms of Medical-Engineering Collaboration Have Thoroughly Subverted the Traditional Cognition of Engineering Teams. The relationship between medicine and engineering is not one of two contracting parties, but rather a collaborative partnership, where communication is even more critical than mere coordination.Over these 15 years, the two teams learned from each other and developed a tacit understanding in their R&D collaboration. It was on this foundation that the “Rocket Heart” was born.

Currently, the team at Rocketheart Technology Co., Ltd. is developing the second-generation “Rocket Heart,” which is currently undergoing registration testing.According to Han Zhifu, the second-generation “Rocketheart” will undergo further technological upgrades, providing heart failure patients with a safer, more reliable, and scientifically advanced domestically produced ventricular assist device.

In the future, Rocketheart Technology Co., Ltd. will continue to uphold its original aspiration and keep its mission firmly in mind, deepen its expertise in the field of artificial assist hearts, and provide new treatment options for more patients with heart failure.